Ruxolitinib for the Treatment of Acute Respiratory Distress Syndrome in Patients With COVID-19 Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-25

Study Completion Date

2020-05-31

Brief Summary

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It is an observational, cohort, retrospective, monocentric, non-profit study. The primary objective is to evaluate the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.

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Detailed Description

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It is an observational, cohort, retrospective, monocentric, non-profit study. Patients with SARS-CoV-2 COVID-19 pneumonia who started off-label Ruxolitinib treatment in the period between 25/03/2020 and 07/04/2020 in hospitalization in the COVID-19 wards of the USL Toscana Nord Ovest company.

Primary objective

\- Evaluation of the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.

Secondary objectives

* Improvement of respiratory performance.
* Improvement of acute phase inflammation indices.
* Evaluation of known adverse events related to the use of the drug.
* Evaluation of the epidemiological parameters in COVID-19 patients.
* Monitoring of plasma levels of cytokines before and after treatment. Exploratory objectives
* Analysis of the outcomes for the launch of a study on the efficacy and safety of Ruxolitinib in the treatment of ADRS in COVID-19 patients.

Conditions

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Severe Acute Respiratory Syndrome Coronavirus 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients treated with ruxolutinib

SARS-CoV-2 COVID-19 patients with rapid worsening of respiratory parameters in the last 12 hours treated with ruxolutinib, dosage of at least 20 mg x 2 / day in the first 48 hours.

Ruxolitinib Oral Tablet

Intervention Type DRUG

Ruxolitinib Oral Tablet dosage of at least 20 mg x 2 / day in the first 48 hours

Interventions

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Ruxolitinib Oral Tablet

Ruxolitinib Oral Tablet dosage of at least 20 mg x 2 / day in the first 48 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* positive analysis for RT PCR (Shanghai BioTec or Sansure Biotech) for SARS-CoV-2 in a respiratory tract sample;
* Imaging (CT / ECO / RX) positive for pneumonia;
* Oxygen saturation (SaO2) of 93% or less in the environment;
* Partial oxygen pressure ratio (PaO2) on inspired oxygen fraction (FiO2) (PaO2 / FiO2) lower than 250 mg / Hg, but not lower than 100 mg / Hg;
* Rapid clinical evolution with worsening of respiratory parameters in the last 12 hours.
* Release of informed consent.

Exclusion Criteria

* Pregnancy and breastfeeding;
* Patients already in assisted breathing with tracheal cannula;
* Patients with active and uncompensated serious pathologies previously to the COVID 19 infection;
* Known hypersensitivity to ruxolitinib or to any of the excipients listed in section 6.1 of the SPC;
* Patients with renal insufficiency;
* Patients with positive quantiferon;
* Patients with documented uncontrolled bacterial sepsis (excluding procalcitonin increase in the presence of negative blood cultures);
* Patients with neutropenia equal to or less than 1000 PMN / mmc;
* Patients with thrombocytopenia equal to or less than 100000 / mmc.
* HCV and / or HBV positive patients, HIV.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No